Latest News | Dec 5, 2022

P4ADNow Urges Congress To Prioritize Patients By Promoting Competition And Lowering Drug Prices By Including Bipartisan Reform To FDA’s Citizen Petition Process In End-Of-Year Budget Package

P4ADNow Urges Congress To Prioritize Patients By Promoting Competition And Lowering Drug Prices By Including Bipartisan Reform To FDA’s Citizen Petition Process In End-Of-Year Budget Package

WASHINGTON, D.C. — As Congress works towards finalizing an end-of-year budget package, Patients For Affordable Drugs Now (P4ADNow) sent a letter today urging the Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce to boost generic competition and lower prescription drug prices by including the bipartisan legislation Ensuring Timely Access to Generics Act (S.562) in the end-of-year budget package. This bill addresses abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to speed approval of more affordable generic drugs to lower prices for patients and save the government hundreds of millions of dollars. P4ADNow was joined on the letter by the Alliance of Community Health Plans (ACHP), American College of Physicians, American Society of Health-System Pharmacists (ASHP), Blue Cross Blue Shield Association, The Campaign for Sustainable Rx Pricing, Friends of Cancer Research, and Protect Our Care.

“In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package,” reads the letter. “CBO reports the reform will save the government $207 million over ten years.” 

Currently, the citizen petition process is often misused by brand name drug manufacturers that submit sham petitions in an effort to delay or block generic approval and market entry. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), would strengthen the citizen petition process, more effectively weeding out petitions that are filed with the intent to delay the approval of generics or biosimilars. The bill restores the integrity of the process, decreases administrative burden on the FDA, and will improve speedy patient access to more affordable generics and biosimilars. 

“Passing the bipartisan citizen petition bill would be a win-win for Congress – it boosts competition by decreasing barriers for cheaper generic drugs to come to market, driving down prices for patients and saving the government hundreds of millions of dollars,” said David Mitchell, a patient with incurable blood cancer whose drugs carry a list price of more than $900,000 per year and founder of Patients For Affordable Drugs Now. “We are grateful for Sens. Shaheen, Cassidy, Bennet, Rubio, and Baldwin’s leadership in advocating for this important reform to ensure the system works as intended for patients and consumers.” 

In addition to the citizen petition bill, P4ADNow also supports inclusion of two other priority bills in Congress’ end-of-year budget – Retaining Access and Restoring Exclusivity (RARE) Act (S. 4185) and Increasing Transparency in Generic Drug Applications Act (H.R. 7032) – which will clarify orphan drug exclusivity to crack down on prolonged monopolies and enhance the FDA’s authority to communicate with generic competitors. 

Read the full letter and list of signers here and below.

December 5, 2022

The Honorable Patty Murray
Chairwoman
U.S. Senate Committee on
Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

The Honorable Richard Burr
Ranking Member
U.S. Senate Committee on
Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

​​The Honorable Frank Pallone
Chairman
U.S. House Committee On Energy and
Commerce
2152 Rayburn House Office Building
Washington, DC 20515

The Honorable Cathy McMorris Rodgers
Ranking Member
U.S. House Committee on Energy and
Commerce
2152 Rayburn House Office Building
Washington, DC 20515

Dear Chairwoman Murray, Ranking Member Burr, Chairman Pallone, and Ranking Member McMorris Rodgers,

As Congress works toward finalizing an end-of-year budget package, we urge the chambers to include bipartisan legislation to address abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to reduce drug prices and save the government hundreds of millions of dollars by speeding generics to market to increase competition. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), strengthens the FDA’s ability to reject citizen petitions if it believes the primary purpose of the petition is to delay approval of a generic competitor. CBO reports the reform will save the government $207 million over ten years. Sen. Baldwin (D-WI) offered the legislation as an amendment during the Senate HELP Committee’s mark-up of the FDA user fee reauthorization legislation; it passed with a strong, bipartisan 16-6 vote.

The citizen petition process at the FDA is intended to provide a forum for patients, consumer groups, and other entities to raise safety concerns about FDA decision making, including drug approvals. Too often, however, this process is co-opted by brand-name drug companies to delay competition. Currently, the FDA must delay authorization of any drug in order to process all citizen petitions. Brand drug companies often game the system by raising invalid, outdated, or extraneous issues in order to block or slow competition from generic products that are poised to enter the market. To that point, research has revealed that brand-name drug makers were behind 92% of all 505(q) citizen petitions filed between 2011 and 2015. Overwhelmingly, these petitions were “shams,” not raising legitimate safety concerns, which is why the FDA threw out nine of every 10 of these petitions.

Both the Trump and Biden administrations have identified submission of sham citizen petitions as a threat to timely approval of generics and competition. In 2018, Former FDA Commissioner Scott Gottlieb noted that manipulation of the process “can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making” and decrease the speed of the approval process. In its 2021 drug pricing competition plan, the Biden administration also said that legislative changes were needed to “make it harder for brand manufacturers to abuse the regulatory process to prevent the introduction of biosimilar and generic products” such as through manipulation of the citizen petition process.

In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package.

Sincerely,

Patients For Affordable Drugs Now
Alliance of Community Health Plans
American College of Physicians
American Society of Health-System Pharmacists
Blue Cross Blue Shield Association
The Campaign for Sustainable Rx Pricing
Friends of Cancer Research
Protect Our Care

CC: Leader Schumer, Speaker Pelosi, Minority Leader McConnell, and Minority Leader McCarthy

Click here for PDF of letter

December 5, 2022

The Honorable Patty Murray
Chairwoman
U.S. Senate Committee on
Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

The Honorable Richard Burr
Ranking Member
U.S. Senate Committee on
Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

​​The Honorable Frank Pallone
Chairman
U.S. House Committee On Energy and
Commerce
2152 Rayburn House Office Building
Washington, DC 20515

The Honorable Cathy McMorris Rodgers
Ranking Member
U.S. House Committee on Energy and
Commerce
2152 Rayburn House Office Building
Washington, DC 20515

Dear Chairwoman Murray, Ranking Member Burr, Chairman Pallone, and Ranking Member McMorris Rodgers,

As Congress works toward finalizing an end-of-year budget package, we urge the chambers to include bipartisan legislation to address abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to reduce drug prices and save the government hundreds of millions of dollars by speeding generics to market to increase competition. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), strengthens the FDA’s ability to reject citizen petitions if it believes the primary purpose of the petition is to delay approval of a generic competitor. CBO reports the reform will save the government $207 million over ten years. Sen. Baldwin (D-WI) offered the legislation as an amendment during the Senate HELP Committee’s mark-up of the FDA user fee reauthorization legislation; it passed with a strong, bipartisan 16-6 vote.

The citizen petition process at the FDA is intended to provide a forum for patients, consumer groups, and other entities to raise safety concerns about FDA decision making, including drug approvals. Too often, however, this process is co-opted by brand-name drug companies to delay competition. Currently, the FDA must delay authorization of any drug in order to process all citizen petitions. Brand drug companies often game the system by raising invalid, outdated, or extraneous issues in order to block or slow competition from generic products that are poised to enter the market. To that point, research has revealed that brand-name drug makers were behind 92% of all 505(q) citizen petitions filed between 2011 and 2015. Overwhelmingly, these petitions were “shams,” not raising legitimate safety concerns, which is why the FDA threw out nine of every 10 of these petitions.

Both the Trump and Biden administrations have identified submission of sham citizen petitions as a threat to timely approval of generics and competition. In 2018, Former FDA Commissioner Scott Gottlieb noted that manipulation of the process “can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making” and decrease the speed of the approval process. In its 2021 drug pricing competition plan, the Biden administration also said that legislative changes were needed to “make it harder for brand manufacturers to abuse the regulatory process to prevent the introduction of biosimilar and generic products” such as through manipulation of the citizen petition process.

In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package.

Sincerely,

Patients For Affordable Drugs Now
Alliance of Community Health Plans
American College of Physicians
American Society of Health-System Pharmacists
Blue Cross Blue Shield Association
The Campaign for Sustainable Rx Pricing
Friends of Cancer Research
Protect Our Care

CC: Leader Schumer, Speaker Pelosi, Minority Leader McConnell, and Minority Leader McCarthy

Click here for PDF of letter

Welcome To The Week In Review.

  1. Inflation Reduction Act: A Victory For Patients

2. Big Pharma Watchdog Alerts

3. Spotlight on Congress: Drug Prices Matter

BONUS: This #WorldAIDSDay, we recognized that people living with HIV/AIDS face exorbitant prices for essential drugs because of price gouging from Big Pharma. Gilead Sciences, which has a monopoly on many essential HIV and AIDS medications, price gouges patients taking its HIV antiviral treatment Biktarvy, charging more than $3,500 a month for a drug that is keeping people alive. We must continue to fight for equitable access to life-saving drugs. 

Have a great weekend, everyone!

Happy Thanksgiving from P4AD! We’re immensely grateful for the historic progress made to lower drug prices this year.

Welcome To The Week In Review.

  1. Election Results: Votes For Lower Drug Prices

2. #WorldDiabetesDay

3. STAT Summit 2022

STAT’S RACHEL COHRS, DAVID MITCHELL, AND GUNNAR ESIASON

Have a great weekend, everyone!

Happy Veterans Day! Hope everyone is resting up post-election.

Welcome To The Week In Review.

  1. Drug Pricing + The Election

2. We Need Patent Reform

3. Lower Drug Prices Now

Have a great weekend, everyone!

This No-vember we’re saying no to high drug prices.

Welcome To The Week In Review.

  1. Sheldon and President Biden

2. Patients Say No To GOP Bill

3. No Good Reason For High Rx Prices

4. Patients Are Suffering From High Drug Prices

5. Big Pharma’s Latest Scapegoat, Same BS

?️BONUS: It’s nearly election day! And drug prices are still top of mind as Americans cast their ballots. Patient advocate Jackie Trapp, who lives with a ​​rare blood cancer, told CBS this week that she’s planning on voting for Democrats, and that “she’s looking forward to seeing those [drug] costs drop in coming years as drug-pricing provisions of the Inflation Reduction Act kick in.”

Have a great weekend, everyone!

FLORIDA — Patient advocate Sheldon Armus, a Medicare beneficiary from Boynton Beach, shared his story about the high price of his cardiac medications today and introduced President Biden, thanking him for passing the Inflation Reduction Act that will lower drug prices and improve the health of millions of patients. The president delivered remarks in Hallandale Beach about lowering prescription drug costs through the Inflation Reduction Act and protecting Social Security and Medicare.

Sheldon, 74, takes Xarelto and Brilinta, blood thinners that prevent him from developing dangerous blood clots that could lead to a heart attack or stroke. Sheldon explained that Johnson & Johnson has raised the price of Xarelto every year, far outpacing the rate of inflation. It now costs $500 for a 30-day supply, whereas if it had been held to the rate of inflation since 2013, its price would be less than $300 for a month’s supply.

The provisions in the Inflation Reduction Act will, for the first time, allow Medicare to negotiate lower drug prices, curb annual drug price increases to no more than the rate of inflation, cap out-of-pocket costs for Medicare Part D beneficiaries at $2,000 in 2025, limit monthly insulin copays to $35 per month for Medicare beneficiaries, and make adult vaccines free for Medicare beneficiaries starting next year.

“Medicare is gonna have the power to negotiate lower drug prices,” said President Biden at today’s speech. “The total amount of prescription drug prices you have to pay in any one year if you’re a senior on Medicare…will not be more than $2,000 a year – that’s it.”

“Sheldon is a tremendous advocate and we are grateful he shared his story while introducing the president today,” said Merith Basey, Patients For Affordable Drug Now’s Executive Director. “The Inflation Reduction Act will lower costs for hundreds of thousands of Floridians like Sheldon which will make a significant difference in improving their lives. This is one of the many reasons the drug price provisions are supported by almost 80 percent of Americans, including seven out of 10 Republicans.”

Sheldon added: “Knowing that we have leaders like President Biden fighting to bring down our drug prices — not keep money in the pockets of the pharmaceutical companies — means the world to seniors like my wife and myself, who have been waiting on this relief for years.”

Watch Sheldon’s remarks and the president’s full speech here.

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Thanks to the Inflation Reduction Act, millions of patients won’t get Tricked by Big Pharma, only Treated to lower drug prices ?

Welcome To The Week In Review (a day early, as P4AD is closed today).

  1. Popular Provisions

2. Patient Feature: Therese Humphrey Ball

3. Patients Footing The Bills

Have a great weekend, everyone!